Heart valve anchoring device

ABSTRACT

The present invention relates to an anchoring device ( 1 ) designed for anchoring a prosthetic heart valve inside a heart, comprising an extraventricular part ( 2 ) designed to be positioned inside an atrium or an artery and a ventricular part ( 3 ) designed to be positioned inside a ventricle, wherein the ventricular part comprises a double wall composed of an outer wall ( 4 ) and an inner wall ( 5 ) spaced apart at the level where the prosthetic heart valve is intended to be inserted, and wherein the anchoring device further comprises a predefined V-shaped groove ( 8 ) formed between the extraventricular part ( 2 ) and the ventricular part ( 3 ). The present invention also relates to an anchoring system ( 11 ) for anchoring a prosthetic heart valve inside a heart, comprising said anchoring device ( 1 ), a prosthetic heart valve support ( 12 ) and a prosthetic heart valve ( 13 ) connected to the prosthetic heart valve support ( 12 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/112,311 filed on Jul. 18, 2016, which is a United States nationalphase application under 35 U.S.C. § 371 of International Application No.PCT/EP2015/051037 filed on Jan. 20, 2015 and claims the benefit of EPPatent Application No. 14151825.8 filed on Jan. 20, 2014, the contentsof which are herein incorporated in their entirety by reference. TheInternational Application was published as International Publication No.WO 2015/107226 on Jul. 23, 2015.

FIELD OF INVENTION

The present invention relates to an anchoring device for a heart valve.More particularly the present invention relates to a self-expandinganchoring device designed for implantation of a prosthetic heart valvein a mammalian heart, preferably a human heart.

BACKGROUND OF INVENTION

Valvular heart disease is recognized as a common disease in the elderlypopulation. Prevalence of valvular heart diseases increases indeed withage, from 0.7% in 18-44 year olds to 13.3% in the 75 years and oldergroup (Nkomo, V T. et al., Burden of valvular heart disease: apopulation-based study, The Lancet, Volume 368, Issue 9540, Pages1005-1011, 2006),

A mammalian heart valve comprises four heart valves which determine thepathway of blood flow through the heart. A mammalian heart generallycomprises two atrioventricular valves namely the mitral valve and thetricuspid valve, which are located between the atria and the ventriclesand prevent backflow of blood from the ventricles into the atria; andtwo semilunar valves (also known as arterioventricular valves) namelythe aortic valve and the pulmonary valve, which are located in thearteries leaving the heart and prevent backflow of blood from thearteries into the ventricles.

The mitral valve, also known as the left atrioventricular valve, iscomposed of two valve leaflets (anterior and posterior), an annulus, asupporting chordae tendinae, and papillary muscles. The tricuspid valve,also known as the right atrioventricular valve, is made up of threevalve leaflets (anterior, posterior and septal), an annulus, asupporting chordae tendinae, and papillary muscles. The aortic valve iscomposed of three valve leaflets (right, left and posterior) and anannulus. The pulmonary valve is made up of three valve leaflets (right,left and anterior) and an annulus. The fibrous aortic annulus, thefibromuscular pulmonary annulus and the muscular tricuspid and mitralannuli are linked to the leaflets. As the heart beats, the leaflets openand close to control the flow of blood. The leaflets of theatrioventricular valves are prevented from prolapsing into the atrium byaction of the papillary muscles, connected to the leaflets via thechordae tendinae.

Mitral regurgitation—the mitral leaflets do not close properly leadingto abnormal leaking of blood—is the most commonly occurring valveabnormality. In the US, in every age group, mitral regurgitation is themost common valvular disorder with a global prevalence of 1.7%,increasing to 10% in adults above 75 years old. (Nkomo, V T. et al.,Burden of valvular heart disease: a population-based study, The Lancet,Volume 368, Issue 9540, Pages 1005-1011, 2006). Besides mitralregurgitation, conditions affecting the proper functioning of the mitralvalve also include mitral valves stenosis—the opening of the mitralvalve is narrowed leading to systolic function deterioration. Aorticvalve, pulmonary valve and tricuspid valve may also be affected byregurgitation and stenosis. Heart valve regurgitation and stenosis havestrong humanistic outcomes.

Typically, treatment for heart valve regurgitation or stenosis involveseither administration of diuretics and/or vasodilators to reduce theamount of blood flowing back, or surgical procedures for either repairor replacement of the heart valve. Repair approach involves cinching orresecting portions of a dilated annulus, for example by implantation ofannular rings which are generally secured to the annulus or surroundingtissue. Alternatively, more invasive procedure involves the replacementof the entire heart valve; mechanical heart valves or biological tissuesare implanted into the heart in place of the native heart valve. Theseinvasive procedures are performed either through large openthoracotomies or by percutaneous route.

However, in many repair and replacement procedures, the durability ofthe devices, or the improper sizing of annuloplasty rings or replacementheart valves, may result in additional issues for the patients. For thisreason a significant part of patients with valvular heart diseases aredenied for surgery. Indeed, despite guidelines for the management ofpatients with valvular heart disease, 49% of patients with severe mitralregurgitation, assessed by Doppler-echocardiography, are not referred tofor surgery; mainly because of their advanced age, the presence ofcomorbidities, or impaired left ventricular ejection fraction (Mirabel,M. et al., What are the characteristics of patients with severe,symptomatic, mitral regurgitation who are denied surgery, European HeartJournal, Volume 28, Pages 1358-1365, 2007).

Less invasive approaches recently implemented involve pre-assembled,percutaneous expandable prosthetic heart valves. U.S. Pat. No. 5,840,081discloses a method for implanting an aortic valve mounted on anexpandable stent. However, human anatomical variability makes itdifficult to design and size a prosthetic heart valve having the abilityto conform to a heart annulus. Especially percutaneous atrioventricularvalve replacement is a real challenge as the native atrioventricularvalves annuli have a non-circular, non-planar, saddle-like geometryoften lacking symmetry.

Technical Issue

According to the Applicant, as a prosthetic heart valve needs a stableand symmetric support during the cardiac cycle to ensure properfunctioning, there is a need for devices enabling proper anchoring ofprosthetic heart valve within the native heart valve. There is also acontinued need to provide a prosthetic heart valve avoiding orpreventing trauma to the surrounding tissue and ensuring properfunctioning even in case of cardiac valve fibrosis.

Current devices developed for percutaneous heart valve replacement werefound unsuitable for the following reasons:

-   -   Firstly, many of these existing devices support the prosthetic        heart valve while contacting the annulus; thereby directly        transferring to the prosthetic heart valve many of the        distorting forces exerted by the surrounding tissue and blood as        the heart contracts during each cardiac cycle. As cardiac        replacement devices further comprise heart valves which require        a substantially symmetric, cylindrical support around the        prosthetic heart valve for proper opening and closing of the        leaflets over years of life, when these devices are subjects to        movement and forces from the annulus and other surrounding        tissues, the prostheses may be compressed and/or distorted,        causing the prosthetic leaflets to malfunction. For example        International Patent Application WO 2009/106545 discloses an        expandable stent for the positioning and anchoring of valvular        prosthesis in an implantation site in the heart of a patient in        the treatment of a narrowed cardiac valve (stenosis) or a        cardiac valve insufficiency (regurgitation). In this        application, the stent comprises at least one fastening portion        via which the valvular prosthesis can be connected to the stent.        This stent is designed as a single wall structure with a        circular section and does not address the issue of geometrical        unpredictability. Such device does not really prevent        paravalvular leakage. Indeed, as the supporting tissue does not        offer a stable circular section, junction between the stent and        the native heart valve is not achieved on the entire periphery        of the heart valve. Moreover, with a single wall structure the        stent does not mechanically isolate the prosthetic heart valve        from the surrounding native tissues, thereby preventing proper        functioning of the prosthetic heart valve during each cardiac        cycle.    -   Secondly, common stents provide radial anchorage and may migrate        or slip relative to the heart wall due to blood flow, movements        and forces from the annulus and other surrounding tissues. Some        existing devices may overcome this drawback by providing an        anchoring device comprising a plurality of hook-shaped elements        as disclosed in International Patent Application WO 2001/64137.        However, this circular device is inflexible and the seal between        the anchoring device and the native heart valve and surrounding        tissues is hard to achieve. Furthermore, radial support of the        surrounding tissue of an atrioventricular valve is significantly        lower than radial support of the surrounding tissue of an aortic        valve. Therefore radial anchorage of a stent designed for aortic        valve may be insufficient when used for atrioventricular valve        replacement.    -   Thirdly, minimally invasive procedure, without direct vision of        the surgical site, strongly relies on cardiac surgeon's skills.        The prosthetic heart valve must be able to be maneuvered to the        greatest possible extent during implantation procedure so as to        ensure optimum positioning accuracy. Misalignment of the        anchoring device may indeed lead to leakage and unsealing of the        device. International patent application WO 2006/128185        discloses an intravascular cuff, with two mushroom-like ends        which, upon deployment, trap the native heart valve. The two        ends are released sequentially: in a first step the first end is        expanded and may abut against the native heart valve for        ensuring proper placement; and in a second step the second end        is expanded, thereby completely encasing the native heart valve        in the cuff. However, WO 2006/128185 does not disclose a        double-wall device at the height of the prosthetic heart valve,        but only at the two ends. On a practical point of view, WO        2006/128185 discloses the replacement of the native heart valve        in two steps. Firstly, the cuff is released from a first        catheter and traps the native heart valve and secondly, an        expandable prosthetic heart valve is released from a second        catheter inside the lumen of the expanded cuff. Upon expansion        of the prosthetic heart valve inside the cuff from the second        catheter, the prosthetic heart valve expands the central lumen        of the cuff and presses against the native heart valve (cf.        [0026] and FIGS. 6 and 7). Consequently, the cuff disclosed by        WO 2006/128185 directly transfers the forces exerted by the        native heart valve and surrounding tissue to the prosthetic        heart valves. Furthermore, the shape of the mushroom-like ends        do not closely fits the native surrounding tissue along their        entire length.

The present invention addresses and intends to correct the drawbacks ofthe devices of the prior art. The present invention thus relates to asystem for anchoring a prosthetic heart valve inside a heart(hereinafter referred to as the anchoring system) comprising aself-expanding anchoring device (hereinafter referred to as theanchoring device) and a compressible and expandable prosthetic heartvalve support—including a prosthetic heart valve—attached to theanchoring device. The anchoring device of the invention comprises: anextraventricular part, a ventricular part comprising a double wall and apredefined V-shaped groove formed between the extraventricular part andthe ventricular part. Thus, the anchoring device of the invention (i)provides a geometrical anchorage with both radial sealing andlongitudinal support, (ii) prevents direct transfer to the prostheticheart valve of the forces exerted by the surrounding tissue as the heartcontracts during each cardiac cycle and (iii) mechanically isolates theprosthetic heart valve from the surrounding tissue.

SUMMARY

In a first aspect, the invention relates to an anchoring device foranchoring a prosthetic heart valve support supporting a prosthetic heartvalve inside a heart, said anchoring device comprising anextraventricular part designed to be positioned inside an atrium or anartery, a ventricular part designed to be positioned inside a ventricle,characterized in that said ventricular part comprises a double wallcomposed of an outer wall and an inner wall spaced apart at the levelwhere the prosthetic heart valve is intended to be inserted, and furthercharacterized in that the anchoring device comprises a predefinedV-shaped groove formed between the extraventricular part and theventricular part.

In an embodiment, the outer wall and the inner wall are connected at afolded end.

In an embodiment, the extraventricular part comprises at least oneextraventricular flange extending from the outer wall or the inner wall.

In an embodiment, the ventricular part comprises a cylindrical innerwall and a substantially conical outer wall having its smaller diameterdirected in the direction of the extraventricular part and its largerdiameter connected to the cylindrical inner wall at the folded end.

In an embodiment, the inner wall of the ventricular part defines alongitudinal axis and the ventricular side of the groove presents anangle, with regard to the longitudinal axis and in the direction of theventricular part, ranging from 20° to 80°, and the extraventricular sideof the groove presents an angle, with regard to the longitudinal axisand in the direction of the ventricular part, ranging from 65° to 110°.

In an embodiment, the V-shaped groove exhibits an acute angle rangingfrom 5° to 50°.

In an embodiment, the extraventricular side of the V-shaped groovecomprises the at least one extraventricular flange and the ventricularside of the V-shaped groove comprises the outer wall of the ventricularpart.

In an embodiment, the anchoring device is designed for anchoring aprosthetic heart valve inside a heart, and comprises an extraventricularpart designed to be positioned inside an atrium or an artery, aventricular part designed to be positioned inside a ventricle, an outerwall and an inner wall, wherein said outer wall and said inner wall arespaced apart at the level where the prosthetic heart valve is intendedto be inserted in order to mechanically isolating the inner wall fromthe outer wall.

In an embodiment, the anchoring device is totally or partially made of abiocompatible alloy such as stainless steel, Nitinol, or cobalt-chromiumalloy.

In this embodiment, preferably, outer wall and inner wall are one singlepiece.

In an embodiment, the outer wall and the inner wall and the inner wallare connected at the end of the ventricular part.

In an embodiment, the anchoring device is made from a flexible braidedmesh.

In an embodiment, the anchoring device further comprises a covercovering totally or partially the anchoring device, said cover beingpreferably made of biological tissue, silicone, polytetrafluoroethylene,polyurethane, polyamide, polyester or mixture thereof.

In an embodiment, the anchoring device further comprises a plurality ofarms extending outwardly from the ventricular part in the direction ofthe extraventricular part for securing the native leaflets.

The invention also relates to an anchoring system for anchoring aprosthetic heart valve inside a heart, comprising an anchoring device asdescribed herein, a prosthetic heart valve support, preferably aself-expanding prosthetic heart valve support, and a prosthetic heartvalve connected to the prosthetic heart valve support.

In an embodiment, the prosthetic heart valve support is inserted in thelumen defined by the inner wall of the ventricular part and connected tothe inner wall of the ventricular part.

In an embodiment, the anchoring system of the invention is such that theprosthetic heart valve support has higher stiffness than the anchoringdevice. This embodiment is advantageous in that it may help the outerwall of the anchoring device to fit closely the heart wall around thenative heart valve during each cardiac cycle, while the prosthetic heartvalve support keeps a stable cross-section ensuring proper functioningof the prosthetic heart valve.

In an embodiment, the anchoring system of the invention is crimped inthe lumen of a catheter.

In an embodiment, the anchoring system is be crimped in the lumen of acatheter with the ventricular part located distally in the catheter, theventricular part and the extraventricular part are released out of thecatheter sequentially, and:

-   -   upon release of the ventricular part out of the catheter, the        ventricular part expands and provides a mechanical stop which        protrudes radially with respect to the catheter and presents an        angle of about 90°, with respect to the longitudinal axis of the        anchoring device, and then    -   upon release of the extraventricular part out of the catheter,        the ventricular part returns to its original shape defining a        V-shaped groove with the extraventricular part.

In an embodiment, the anchoring system may be crimped in the lumen of acatheter with the extraventricular part located distally in thecatheter, the wherein the ventricular part and the extraventricularpart, may be released out of the catheter sequentially, and:

-   -   upon release of the extraventricular part out of the catheter,        the extraventricular part expands and provides a mechanical stop        which protrudes radially with respect to the catheter and        presents an angle of about 90°, with respect to the longitudinal        axis of the anchoring device, and then    -   upon release of the ventricular part out of the catheter, the        extraventricular part returns to its original shape defining a        V-shaped groove with the ventricular part

In an embodiment, the anchoring system further comprises a tie whichpasses through the mesh of the anchoring device enabling there-introduction of the anchoring system inside a catheter by turninginversely the outer wall once the anchoring system has been totallydeployed out of said catheter.

In an embodiment, the anchoring system of the invention furthercomprises a cover covering totally or partially the prosthetic heartvalve support, advantageously the cover is made of biological tissue,silicone, polytetrafluoroethylene, polyurethane, polyamide, polyester ormixture thereof.

In an embodiment, in the anchoring system of the invention theprosthetic heart valve support is made a biocompatible alloy such asstainless steel, Nitinol, or cobalt-chromium alloy.

In an embodiment, the anchoring system further comprises a plurality ofarms extending outwardly from the prosthetic heart valve support forsecuring the native leaflets.

This invention also includes a kit of parts for performing heart valvereplacement comprising an anchoring device as described herein, aprosthetic heart valve support, a prosthetic heart valve and optionallya catheter.

Definitions

In the present invention, the following terms have the followingmeanings:

-   -   As used herein the singular forms “a”, “an”, and “the” include        singular and/or plural reference unless the context clearly        dictates otherwise.    -   The term “about” is used herein to mean approximately, roughly,        around, or in the region of. When the term “about” is used in        conjunction with a numerical range, it modifies that range by        extending the boundaries above and below the numerical values        set forth. In general, the term “about” is used herein to modify        a numerical value or range within 20 percent, preferably within        10 percent of said given value or range.    -   “Anchoring device” refers herein to a self-expanding device        designed for allowing the implantation and anchorage of a        prosthetic heart valve in a mammalian heart.    -   “Anchoring system” refers herein to a system comprising the        anchoring device, a prosthetic heart valve support and a        prosthetic heart valve.    -   With regard to the terms “distal” and “proximal” as used herein,        unless otherwise specified, the terms can refer to a relative        position of the portions of an anchoring device and/or an        associated delivery device with reference to an operator (e.g. a        surgeon). For example, referring to a delivery catheter suitable        to deliver and position the anchoring device comprising a        prosthetic heart valve, “proximal” shall refer to a position        closer to the operator of the device or an incision in the human        body, and “distal” shall refer to a position that is more        distant from the operator of the device or further from the        incision.    -   “Double wall” refers herein to two walls spaced apart in order        to mechanically isolating the first wall from the second wall.        In the present invention a device with a double wall refers to a        double walled device along at least the portion intended to        receive the prosthetic heart valve, along the whole ventricular        part or along the entire length of the anchoring device.    -   “Geometrical anchorage” refers herein to the anchorage of the        device relative to the entire heart wall from one end to the        other end of the anchoring device due to an optimal stress        distribution both radially and longitudinally; as seen in FIGS.        4A, 4B and 4C. Within the present invention, the anchoring        device pinches the sub- and supra-annular surfaces without        applying radial force on the annulus.    -   “Paravalvular leak or paraprosthetic leak” refers herein to a        small opening between the upper and lower part of the native        heart valve around the outside of the prosthetic heart valve        and/or the outside of the anchoring device.    -   “Prosthetic heart valve” refers herein to mechanical,        biological, textile, elastomeric or tissue-engineered heart        valves designed to replicate the function of the natural valves        of the human heart.    -   “Radial anchorage” refers herein to the anchorage of a        prosthetic heart wall predominantly by the device radial        expansion force.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an anchoring device according to an embodimentof the present invention.

FIG. 2 is a sectional drawing of the anchoring device according to anembodiment of the present invention.

FIGS. 3A, 3B and 3C are side views of an anchoring device duringdeployment out of a catheter according to an embodiment of the presentinvention.

FIGS. 4A, 4B and 4C are sectional drawings of the outer wall of ananchoring device expanded at the level of a native heart valve, during acardiac cycle, according to one embodiment of the present invention.

FIGS. 5A, 5B, 5C and 5D are side views of an anchoring device, accordingto one embodiment of the present invention, during the sequentialre-introduction of the anchoring device inside a catheter.

FIGS. 6A, 6B, 6C and 6D are side views of an anchoring device duringdeployment out of a catheter according to an embodiment of the presentinvention.

FIG. 7A is a side view of an anchoring system according to an embodimentof the present invention.

FIG. 7B is a top perspective view of an anchoring system according to anembodiment of the present invention.

FIG. 7C is a bottom view of an anchoring system according to anembodiment of the present invention.

FIG. 8 is a sectional view, illustrating the positioning in a humanheart of the anchoring system according to one embodiment of the presentinvention, wherein the deployment has been implemented sequentially withfirst release of the ventricular part and then release extraventricularpart.

FIG. 9 is a sectional view, illustrating the positioning in a humanheart of the anchoring system according to one embodiment of the presentinvention, wherein the deployment has been implemented sequentially withfirst release of the extraventricular part and then release of theventricular part.

FIG. 10 is a side view of an anchoring device according to an embodimentof the present invention.

FIG. 11 is a sectional drawing of the anchoring device according to anembodiment of the present invention.

FIG. 12 is a side view of an anchoring device according to an embodimentof the present invention wherein the anchoring device comprises aplurality of arms extending outwardly from the ventricular part.

FIG. 13 is a side view of an anchoring system according to an embodimentof the present invention wherein the anchoring system comprises aplurality of arms extending outwardly from the prosthetic heart valvesupport.

REFERENCES

-   -   1 Anchoring device    -   2 Extraventricular part of the anchoring device    -   2 d Mechanical stop if the extraventricular part is released in        the first step of the deployment    -   3 Ventricular part of the anchoring device    -   3 d Mechanical stop if the ventricular part is released in the        first step of the deployment    -   4 Outer wall of the anchoring device    -   Inner wall of the anchoring device    -   6 Flange(s) of the extraventricular part    -   7 Cylindrical portion(s) of the extraventricular part    -   8 Groove    -   9 Cover of the anchoring device    -   10 Tie    -   11 Anchoring system    -   12 Prosthetic heart valve support    -   13 Prosthetic heart valve    -   14 Cover of the prosthetic heart valve support    -   Catheter    -   16 Arms    -   A Extraventricular area—atrium or artery    -   V Ventricle

DETAILED DESCRIPTION

The following detailed description will be better understood when readin conjunction with the drawings. For the purpose of illustrating, theanchoring device and the anchoring system are shown in the preferredembodiments. It should be understood, however that the application isnot limited to the precise arrangements, structures, features,embodiments, and aspect shown. The drawings are not drawn to scale andare not intended to limit the scope of the claims to the embodimentsdepicted.

The present invention provides system, device and method to treat heartvalve diseases of a mammalian body, preferably a human body.

The present invention relates firstly to an anchoring device designedfor implantation of a prosthetic heart valve in a mammalian heart,preferably a human heart.

Referring to the drawings, FIG. 1 illustrates an anchoring device 1 madefrom a, preferably one single, flexible, compressible and expansiblemesh and comprising an extraventricular part 2 and a ventricular part 3.The ventricular part 3 is particularly designed to be positioned insidea ventricle and the extraventricular part 2 is particularly designed tobe positioned inside an atrium or inside an artery.

If the anchoring device 1 is designed for anchoring a prostheticatrioventricular valve, the extraventricular part 2 will be positionedin an atrium. If the anchoring device 1 is designed for anchoring aprosthetic semilunar valve, the extraventricular part 2 will bepositioned in an artery.

The anchoring device 1 is of general cylindrical shape.

The anchoring device 1 is a double-walled device. In an embodiment, theanchoring device 1 comprises an outer wall 4 and an inner wall 5. In anembodiment, the inner wall 5 and the outer wall 4 are connected at afolded end and form a single piece.

In an embodiment, the anchoring device 1 is made from a single mesh,forming a general cylindrical shape, folded at one end (the folded end)and extending back up to form an outer wall 4 close and parallel, butspaced, from the inner original wall 5, said outer wall finishing as acylindrical rim.

According to one embodiment, as detailed hereafter, the inner wall 5 andthe outer wall 4 are connected only at the single folded end. In anembodiment, the outer wall 4 and the inner wall 5 are connected at thebottom of the ventricular part 3.

In an embodiment, the anchoring device 1 presents a double wall alongthe whole height of the device 1. In an embodiment, the anchoring device1 presents a double wall along the whole height of the device 1 exceptat the non-folded end. In an embodiment, the anchoring device 1 presentsa double wall at the height of the native heart valve, especially at theheight of the annulus of the native heart valve. In an embodiment, theanchoring device 1 presents a double wall along the ventricular part 3.

In an embodiment, the inner wall 5 is spaced apart from the outer wall 4so that the inner wall 5 is mechanically isolated with respect to thesurrounding tissues. In an embodiment, the outer wall 4 and the innerwall 5 are spaced apart, at least at the level where the prostheticheart valve is intended to be inserted in order to mechanicallyisolating the inner wall 5 from the outer wall 4. In an embodiment, theouter wall 4 and the inner wall 5 are spaced apart at the height of thenative heart valve, especially at the height of the annulus of thenative heart valve. In an embodiment, the outer wall 4 and the innerwall 5 are spaced apart along the ventricular part 3. In an embodiment,the outer wall 4 supports the major part of the stresses from thesurrounding tissues and the inner wall 5 exhibits a stable cross-sectionwhatever the forces exerted by the surrounding tissue. Referring toFIGS. 2 and 11, illustrating a cross sectional view of the anchoringdevice 1, the outer wall 4 is shown in full line and the inner wall 5 isshown in dotted line. In an embodiment, the outer wall 4 and the innerwall 5 have the same stiffness. In an alternative embodiment, the outerwall 4 exhibits lower stiffness than that of the inner wall 5.

According to the invention, the device comprises a groove or a recess 8,designed for accommodating the native heart valve, especially theannulus of the native heart valve. In an embodiment, the groove 8 is atthe junction between the extraventricular part 2 and the ventricularpart 3. In an embodiment, the groove 8 is formed between theextraventricular part 2 and the ventricular part 3. In a preferredembodiment, the groove 8 is V-shaped.

In an embodiment, the groove 8 is designed to accommodate, pinch,contain and press the native heart valve, especially the annulus of thenative heart valve. In an embodiment, the groove 8 has a depth rangingfrom 1 to 30 millimeters, preferably from 5 to 15 millimeters, morepreferably from 5 to 10 millimeters. As explained thoroughly hereafter,it is an object of the groove 8 of the invention to position theanchoring device with respect to the native heart valve due to sub- andsupra-annulus anchoring without radial anchoring at the height of theannulus; thereby avoiding trauma. In a preferred embodiment, theextraventricular part 2, the groove 8 and the ventricular part 3 areintegral and formed in a single piece.

In an embodiment, the extraventricular part 2 of the anchoring device 1comprises at least one extraventricular flange 6 extending from theouter wall 4 and/or from the inner wall 5. In an embodiment, theextraventricular part 2 of the anchoring device 1 comprises twoextraventricular flanges 6 extending from the outer wall 4 and from theinner wall 5.

In an embodiment, the at least one extraventricular flange 6 forms theextraventricular side of the groove 8.

In an embodiment, the extraventricular part 2 of the anchoring device 1comprises at least one cylindrical portion 7 extending from the at leastone extraventricular flange 6 in the direction opposite to theventricular part. In an embodiment, the extraventricular part 2 of theanchoring device 1 comprises two cylindrical portions 7 extending fromeach of the two extraventricular flanges 6.

In the embodiment depicted in FIGS. 1 and 2, the extraventricular part 2of the anchoring device 1 comprises two extraventricular flanges 6extending, one from the inner wall 5, and the other one from outer wall4, and two cylindrical portions 7 extending from each of saidextraventricular flanges 6 in the direction opposite to the ventricularpart 3.

In an embodiment, the extraventricular flange of the inner wall 5 isfolded into itself and the rim of said extraventricular flange isinserted between the outer wall 4 and the inner wall 5 of theventricular part 3. Thus the extraventricular flange 6 of the inner wall5 is located in the ventricular part 3.

In another embodiment depicted in FIGS. 10 and 11, the anchoring device1 comprises only a single extraventricular flange 6 which extends fromthe inner wall 5. The rim of the outer wall 4 of the ventricular part 3is free and not connected to the extraventricular flange 6.

According to an alternative embodiment, not shown, the rim (i.e. thenon-folded end) of the outer wall 4 is connected to the extraventricularflange 6 by any means that one skilled in the art would find suitablesuch as for example suture or mesh interlacing. In an embodiment, theouter wall 4 of the ventricular part 3 is connected to theextraventricular flange 6 along a circle having a diameter rangingbetween D2 and D4.

In an embodiment, the extraventricular flange(s) 6 extends radially withrespect to the longitudinal axis of the anchoring device 1. In anembodiment, the extraventricular flange(s) 6 extends with an angle, withrespect to the longitudinal axis and in the direction of the ventricularpart 3, ranging from 65° to 110°, preferably from 75° to 100°, morepreferably from 85 to 105°. In an embodiment, the outer wall 4 of theventricular part 3 extends with an angle, with respect to thelongitudinal axis and in the direction of the ventricular part 3,ranging from 20° to 80°, preferably from 30° to 60°, more preferablyfrom 40 to 50°.

The extraventricular flange(s) 6 may be constructed of differentgeometric shapes, such as circular, oval, star, petal, or ratchet. Theextraventricular flange(s) 6 may take on different profiles, when viewedfrom its side. In one embodiment, the profile of the extraventricularflange(s) 6 is curved or ridged. The different geometric shapes andprofiles of the extraventricular flange(s) 6 provide better contact,stability and grip between the extraventricular flange(s) 6 and theextraventricular side of the native annulus. The extraventricularflange(s) 6 are configured for positioning substantially flat againstthe extraventricular side of the native annulus to prevent migration ofthe anchoring device 1 in at least one direction following implantation.For instance, if the anchoring device 1 is designed for anchoring aprosthetic mitral valve or prosthetic tricuspid valve, the at least oneextraventricular flange 6 is configured to anchor the extraventricularside (i.e. the atrial side) of the mitral annulus, respectively thetricuspid annulus.

In one embodiment, the cylindrical portions 7 is replaced by a foldedportion, a rounded portion, a conic portion, a cylinder having adiameter of about D2, or a mixture thereof.

In an embodiment, the extraventricular flanges 6 of the outer wall 4 andof the inner wall 5 of the extraventricular part 2 are extended in thedirection opposite to the ventricular part 3 by cylindrical portions 7having a diameter of about D2. Without portion 7, the outer end of themesh of the extraventricular flanges 6 may perforate the atrial orarterial wall. Use of a portion(s), preferably a cylindrical portion(s)7, extending from the extraventricular flange(s) 6 in the directionopposite to the ventricular part 3 limits the risks of puncture of theatrial or arterial wall and provides an atraumatic extraventricular part2. In an embodiment, the inner portion 7 has a height higher than theouter portion 7. In an embodiment, the inner wall 5 of theextraventricular part 2 has a height higher than the height of the outerwall 4 of the extraventricular part 2. In said embodiment, the innerwall 5 of the extraventricular part 2 is higher from 2 to 15millimeters, preferably from 3 to 10 millimeters with respect to theouter wall 4 of the extraventricular part 2. In an embodiment, the innerwall 5 of the extraventricular part 2 and the outer wall 4 of theextraventricular part 2 have the same height. In an embodiment, theouter portion 7 has a height higher than the inner portion 7. In anembodiment, the outer wall 4 of the extraventricular part 2 has a heighthigher than the height of the inner wall 5 of the extraventricular part2.

In an embodiment, the inner wall 5 and the outer wall 4 are spacedapart, except at the height of the extraventricular flanges 6 and thecylindrical portions 7 and at the folded end.

In one embodiment, the extraventricular flanges 6 have the shape of anannulus, the outer circle having a diameter equal to about D2 and theinner circle having a diameter equal to about D4 for theextraventricular flange 6 extending from the inner wall 5, and equal toabout D5 for the extraventricular flange 6 extending from the outer wall4. In an embodiment, said two extraventricular flanges have differentouter diameters.

The inner wall 5 of the ventricular part 3 has a cylindrical crosssection with a diameter equal to about D4. The outer wall 4 of theventricular part 3 has an approximately toroidal shape. In a preferredembodiment, the outer wall 4 of the ventricular part 3 has anapproximately conical shape whose smaller diameter is directed in thedirection of the extraventricular part 2. In an embodiment, the outerwall 4 of the ventricular part 3 has the shape of a conical body whichslopes inwardly in the direction of the extraventricular part 2. In anembodiment, the end of the ventricular part 3, close to the groove 8 andto the extraventricular part 2, has a smaller cross-sectional area thanthe folded end of the ventricular part 3.

In an embodiment, the junction between the approximately toroidal partof the outer wall 4 of the ventricular part and the at least oneextraventricular flange 6 of the outer wall 4 or inner wall 5 defines aV-shaped groove 8. Said V-shaped groove 8 allows pinching or cinching ofthe native heart valve, especially of the annulus of the native heartvalve throughout the cardiac cycle. In an embodiment, a V-shaped groove8 is formed between the extraventricular flange 6 and the outer wall 4of the ventricular part 3.

The V-shaped groove 8 has a first extraventricular side (theextraventricular flange 6 of the inner wall 5 or the outer wall 4)extending with an angle, with respect to the longitudinal axis and inthe direction of the ventricular part, ranging from 65° to 110°,preferably from 75° to 100°, more preferably from 85 to 105°. TheV-shaped groove 8 has a second ventricular side (the outer wall 4 of theventricular part 3) extending with an angle, with respect to thelongitudinal axis and in the direction of the ventricular part, rangingfrom 20° to 80°, preferably from 30° to 60°, more preferably from 40 to50°. The longitudinal axis is defined as the longitudinal axis of theinner wall 5 of the ventricular part 3. Said V-shaped groove 8 allowseasy positioning of the native heart valve, preferably of the annulus ofthe native heart valve, inside said groove 8. In an embodiment, theV-shaped groove exhibits an acute angle between the edges of the groove.In an embodiment, the V-shaped groove 8 exhibits an angle ranging from5° to 50°, preferably ranging from 10° to 30°.

In an embodiment, the anchoring device 1, and especially the groove 8,enables anchorage at a native heart valve location by engagement withsub-annular and super-annular surfaces of the heart valve annulus and/orvalve leaflets. In an embodiment, the V-shaped groove 8 has a depthranging from 1 to 30 millimeters, preferably from 5 to 15 millimeters,more preferably from 5 to 10 millimeters. In an embodiment, the V-shapedgroove 8 enables self-positioning of the anchoring device 1. Indeed theV-shaped groove 8 is positioned by itself with the bottom of theV-shaped groove 8 in the plane defined by the valvular annulus due tothe two inclined sides of the groove 8. Thus the anchoring device 1 isprecisely positioned with respect to the native heart valve anatomywhile other devices without groove or with U-shaped, C-shaped orrounded-bottom grooves do not provide such precision andself-positioning. The V-shaped groove 8 of the present invention alsoprevents any migration of the anchoring device 1 with respect to thevalvular annulus. Furthermore, the V-shaped groove 8 enables to anchorthe anchoring device with the sub- and supra-annulus surface. Theannulus does not contact the bottom of the V-shape groove thus avoidingradial compression of the annulus.

In an embodiment, the anchoring device 1, and especially the groove 8,the extraventricular flange(s) 6 and the outer wall 4 of the ventricularpart 3 do not only catch or trap the leaflets of the native heart valvebut also presses said leaflets against, or at least in the direction of,the heart wall. In an embodiment, the anchoring device 1 has theflexibility to adapt and conform to the variably-shaped native heartvalve anatomy while mechanically isolating the prosthetic heart valve.The outer wall 4 is indeed in close contact with the atrial or arterialwall, with the ventricular wall, and with the native heart valve andannulus; while the inner wall 5 is mechanically isolated due to thedouble wall and the low stiffness of the anchoring device 1. In anembodiment, the inner wall 5 of the ventricular part 3 has a stablecross section with a diameter equal to about D4, for receiving theprosthetic heart valve.

According to one embodiment, the outer wall 4 spaced from the inner wall5 at the height of the prosthetic heart valve enables proper functioningof prosthetic heart valve even in case of valve fibrosis. Valve fibrosisrefers to abnormal thickening of the heart valve. In the event of valvereplacement the native leaflets of the replaced valve do not open andclose regularly thereby leading to thickening and fibrosis. Saidfibrosis and thickening prevent optimal functioning of standardprosthetic heart valve. Due to the double wall of the present invention,the prosthetic heart valve of the present invention is not obstructed bythe thickened leaflets. The outer wall 4 maintains indeed advantageouslythe valvular apparatus against or in the direction of the heart wall,away from the inner wall 5 and the prosthetic heart valve.

In an embodiment, a U-shaped groove 8 is formed between theextraventricular flange 6 and the outer wall 4 of the ventricular part3.

According to one embodiment, as depicted in FIG. 12, the anchoringdevice 1 further comprises a plurality of arms 16 for securing thedevice with respect to the native heart valve. The plurality of arms 16extends outwardly from the ventricular part 3, preferably from the outerwall 4 of the ventricular part 3. According to one embodiment, theplurality of arms extends outwardly from the folded end of theventricular part 3 in the direction of the extraventricular part 2. Saidplurality of arms 16 are configured to be size and shape for providing apositioning and anchoring function when the anchoring device 1 isdeployed at the native heart valve location.

In one embodiment, the plurality of arms 16 has a length sufficient toextend completely into engagement with the annulus tissue behind theleaflets. According to one embodiment, the plurality of arms 16comprises arms with various lengths and thereby various modes ofengagement with the leaflets or other native tissue.

The plurality of arms 16 may alternatively be configured to engage orcouple to the chordae, papillary muscles, leaflets or ventricular wallsto enhance anchoring. In one embodiment, each arms of the plurality ofarms 16 have independent lengths. In one embodiment, the native leafletsare pinched or sandwiched between the plurality of arms 16 and the outerwall 4.

According to one embodiment, the plurality of arms 16 is formedintegrally with the ventricular part 3, especially with outer wall 4 ofthe ventricular part 3. According to another embodiment, the pluralityof arms 16 is separate component that are attached to the ventricularpart 3. According to one embodiment, the plurality of arms 16 is madefrom the same material than the outer wall 4 of the anchoring device 1.

According to an embodiment (not depicted), the anchoring device 1 alsocomprises a grabbing mechanism on the outer wall 4, preferably on theouter wall 4 of the ventricular part 3. In an embodiment, the grabbingmechanism comprises a plurality of projections, preferably anchors,hooks or barbed projections. Said grabbing mechanism at least partiallypenetrates and engages the surrounding tissue and preferably the nativeleaflets. In one embodiment, the grabbing mechanism is positionedoutwardly on the outer wall 4, preferably on the outer wall 4 of theventricular part 3, for instance in one or more horizontal orcircumferential strips. Preferably the grabbing mechanism is located onthe outer wall 4 of the ventricular part 3 in the V-shaped groove 8.According to one embodiment, the projections may have different lengths.According to one embodiment, the grabbing mechanism projects outwardlyfrom 1 to 3 millimeters from the outer wall, preferably from 1 to 2millimeters. According to one embodiment, the grabbing mechanism isoriented towards the extraventricular part 2. According to oneembodiment, the grabbing mechanism is made from the same material thanthe outer wall 4 of the anchoring device 1.

The combination in an embodiment of the anchoring device 1 of thepresent invention of the double wall (i.e. the outer wall 4 and theinner wall 5 spaced apart but connected at a folded end and the V-shapedgroove 8) with the plurality of arms 16 and/or the grabbing mechanismenables maintaining and containing the valvular apparatus and especiallythe native leaflets in a fixed position; thereby ensuring properfunctioning of the prosthetic heart valve to be inserted in theanchoring device. Indeed the anchoring device 1 advantageously containsand maintains the native leaflets due to the combination of:

-   -   the double wall, maintaining the native leaflets in the        direction of the heart wall, away from the prosthetic valve;    -   the plurality of arms 16 and/or the grabbing mechanism fixedly        maintaining and containing the native leaflet with respect to        the anchoring device 1, preventing undesirable movement; and    -   the plurality of arms 16, and/or the grabbing mechanism, and the        V-shaped groove 8 maintaining and containing the native leaflets        and strongly anchoring the device 1 at the desired location.

Again referring to FIG. 2, D2 refers to the external diameter of theextraventricular part 2; D3 refers to the largest external diameter ofthe ventricular part 3; D4 refers to the internal diameter of theventricular part 3; D5 refers to the smallest external diameter of theventricular part or equally to the external diameter at the height ofthe groove 8. Ill refers to the height of the whole anchoring device 1;H2 refers to the height of the extraventricular part 2, preferably ofthe height of the outer wall 4 of the extraventricular part 2; and H3refers to the height of the ventricular part 3. Said diameters andheights refer to the diameters and heights of the anchoring device 1 atthe time of manufacture.

In an embodiment, D2 ranges from 10 to 90 millimeters, preferably from20 to 85 millimeters, more preferably from 30 to 70 millimeters.

In an embodiment, D3 ranges from 10 to 90 millimeters, preferably from20 to 80 millimeters, more preferably from 30 to 70 millimeters. In apreferred embodiment, D2 is equal or higher than D3.

In an embodiment, D4 ranges from 5 to 40 millimeters, preferably from 10to 30 millimeters, more preferably from 15 to 25 millimeters.

In an embodiment, D5 ranges from 10 to 75 millimeters, preferably from20 to 70 millimeters, more preferably from 30 to 65 millimeters, evenmore preferably about 35 millimeters.

In an embodiment, H1 ranges from 5 to 50 millimeters, preferably from 10to 40 millimeters, more preferably from 20 to 30 millimeters, even morepreferably about 25 millimeters.

In an embodiment, H2 ranges from 1 to 20 millimeters, preferably from 3to 15 millimeters, more preferably from 5 to 10 millimeters.

In an embodiment, H3 ranges from 1 to 45 millimeters, preferably from 5to 35 millimeters, more preferably from 10 to 25 millimeters, even morepreferably about 15 millimeters.

In an embodiment, the mesh of the anchoring device 1 is a braided mesh,preferably a flexible braided mesh. Said braided mesh allows lowerstiffness, minimal stress, higher conformability and higherdeformability than continuous mesh. Braiding offers goodcompressibility, enhances the conformation with the heart wall andprevents paravalvular leaks. In an embodiment, the mesh of the anchoringdevice 1 may be braided from one or more strands, preferably one strand.In another embodiment, the mesh of the anchoring device 1 may be acontinuous mesh obtained by any means that a person skilled in the artwould find suitable, such as, for example, laser cutting.

In an embodiment, the mesh of the anchoring device 1 is thermoformed inorder to provide the double wall anchoring device 1 of the presentinvention. Said heat treatment uses common technical knowledge known bya person with ordinary skill in the art, such as for examplethermoforming on a heated metal mandrel. During thermoforming, the meshis reverted (i.e. folded into itself), thus forming in a single piece aninner wall 5 connected at a folded end with an outer wall 4.

In an embodiment, the mesh of the anchoring device 1 is compressible andhas a radially collapsed configuration for delivery through a catheterand a radially expanded configuration for deployment.

In an embodiment, the anchoring device 1 keeps its structure (i.e. adouble wall, an extraventricular part, a V-shaped groove and aventricular part) before crimping and insertion in the catheter andduring use. In an embodiment, the anchoring device 1 is not folded intoitself between the delivery configuration and the expandedconfiguration. In an embodiment, the anchoring device 1 is alreadyfolded into itself in the delivery configuration. In an embodiment, theanchoring device comprises before use an outer wall 4 and an inner wall5 connected at a folded end. In an embodiment, the V-shaped groove 8 ispreconfigured or predefined, i.e. the anchoring device 1 alreadyexhibits its V-shaped groove 8 before crimping in the delivery catheter.

In an embodiment, the anchoring device 1 is made from any material thatone skilled on that art would find suitable, such as any biocompatiblematerial. In an embodiment, the anchoring device 1 is made from anybiocompatible alloy that one skilled in the art would find suitable suchas for example a cobalt alloy, preferably a cobalt-chromium alloy;steel, preferably stainless steel; or a biocompatible shape memoryalloy. In an embodiment, the anchoring device 1 is made from a shapememory alloy, preferably Nitinol, allowing faster and easier deploymentand return to its original expanded shape. In an embodiment, theanchoring device is made from Nitinol due to its superelastic andshape-memory features. In an embodiment, the transformation temperatureof the shape memory alloy, preferably Nitinol, ranges from 0° C. to 50°C. In an embodiment, the transformation temperature of the shape memoryalloy is about 37° C. In another embodiment, the transformationtemperature of the shape memory alloy, preferably nitinol, ranges from0° C. to 20° C. in order to allow phase transformation immediately fromthe releasing of the anchoring device 1 in the human body.

In an embodiment, as illustrated in FIG. 3C, the anchoring device 1further comprises a cover 9. In an embodiment, the anchoring device 1comprises a cover 9 covering the anchoring device 1. In an embodiment,the cover 9 partially or totally covers the anchoring device 1. In afirst embodiment, the cover 9 internally or externally covers the outerwall 4 of the anchoring device 1. In a second embodiment, the cover 9internally or externally covers the inner wall 5 of the anchoring device1. In preferred embodiment, said cover 9 is watertight and thus preventsparavalvular or paraprosthetic leakage through the anchoring device 1.In a preferred embodiment, the cover 9 internally or externally coversthe inner wall 5; more preferably internally covers the inner wall 5 ofthe anchoring device 1. In a preferred embodiment, as disclosed in FIG.7B, the cover 9 covers the extraventricular flange 6 of the inner wall 5of the extraventricular part 2 and the entire inner wall 5 of theventricular part 3. In the embodiment of FIG. 3C, the outer wall 4 isuncovered thus allowing ingrowth and interpenetration between the meshof the outer wall 4 and the heart wall, enhancing the anchorage.

In an embodiment, as disclosed in FIG. 3C, the anchoring device 1comprises a tie or a suture 10 releasably linking the anchoring device 1to a catheter 15. In an embodiment, the anchoring device 1 comprises atie 10 extending through some or all of the meshes of the inner wall 5,preferably passing through some or all of the meshes of the rim of theextraventricular flange 6 of the inner wall 5. In an embodiment, the tie10 passes through at least 50% of the meshes of the rim of theextraventricular flange 6 of the inner wall 5. In an embodiment, theanchoring device 1 comprises a tie 10 passing through some or all of themeshes of the outer wall 4, preferably passing through some or all ofthe meshes of the folded end of the outer wall 4. In an embodiment, thetie 10 passes through at least 50% of the meshes of the folded end ofthe outer wall 4. In an embodiment, the tie 10 may slide through themesh. In an embodiment, the tie 10 is made from a resorptive suturestrand. In an embodiment, the tie 10 is made from a non-resorptivesuture strand. Said tie 10 is useful for the removal of the anchoringdevice by re-introduction of the anchoring device 1 inside a catheter 15during implantation of the anchoring device as explained hereafter.

The present invention also relates to a method of delivery andimplantation of an anchoring device designed to anchor a prostheticheart valve inside a native heart valve.

The present method advantageously enables self-positioning of theanchoring device 1 due to the V-shaped groove 8. In particular theV-shaped groove 8 ensures self-positioning of the anchoring device 1 bypositioning the bottom of the V-shaped groove 8 in the plane defined bythe valvular annulus due to the two inclined sides of the groove 8.

Referring now to FIGS. 3A, 3B and 3C and to FIGS. 6A, 6B, 6C and 6D, thedeployment of the anchoring device 1 is illustrated. As well-known fromone skilled in the art, the anchoring device 1 is initially crimped andintroduced inside the lumen of a catheter 15. In a preferred embodiment,the anchoring device 1 is crimped with a cold-working technique. Theassembly of the anchoring device 1 inside a catheter 15 is well known bya person with ordinary skill in the art.

A small incision is achieved to expose a body channel—e.g. an artery ora vein- or the apex of the heart, through which the insertion of thecatheter 15 takes place. The catheter 15 is advanced until the distalend of the catheter 15 crosses the targeted native heart valve. Once thedistal part of the catheter 15 crossed the annulus of the native heartvalve, the anchoring device 1 may be released progressively andsequentially. Depending of the heart valve to be replaced, varioussurgical approaches may be implemented such as for example retrogradetrans-femoral approach or antegrade trans-apical approach forreplacement of an aortic valve, retrograde trans-apical approach forreplacement of a mitral valve, antegrade jugular approach for thereplacement of a tricuspid valve. Depending of the surgical approach,the distal part of the catheter may be located (i) in a ventricle or(ii) in an atrium or an artery. Depending of the surgical approach andthe heart valve to be treated, the anchoring device 1 may be insertedinto the lumen of the catheter 15 with either (i) the ventricular part 3located distally (i.e. at the distal end of the catheter) and theextraventricular part 2 located proximally, or (ii) the extraventricularpart 2 located distally (i.e. at the distal end of the catheter) and theventricular part 3 located proximally.

The following description is related to the deployment of the anchoringdevice 1 out of a catheter 15, wherein the distal end of the catheter 15is located in a ventricle before the beginning of the deployment (cf.FIG. 8). The ventricular part 3 is thus located distally and theextraventricular part 2 is located proximally within the lumen of thecatheter 15. Said deployment is illustrated in FIGS. 3A, 3B and 3C.

Once the distal end of the catheter 15 has been inserted inside aventricle, the catheter 15 is sequentially retracted with respect to theanchoring device 1. First the ventricular part 3 of the anchoring device1 is fully released. In said first step, the ventricular part 3 expandsimmediately and adopts a first shape defining a mechanical stop 3 d, asshown in FIG. 3A. The outer wall 4 of the ventricular part 3 indeed (i)protrudes with respect to the catheter 15 or to the extraventricularpart 2 and (ii) presents proximally an angle of about 90° with respectto the longitudinal axis of the anchoring device 1. The externaldiameter of the mechanical stop 3 d is preferably higher than theinternal diameter of the native heart valve, thus the surgeon may abutthe proximal part of the ventricular part 3 against the sub-annularsurface of the heart valve annulus thereby obtaining a mechanicalfeedback. Indeed the mechanical stop 3 d of the ventricular part 3defines an end-positon as the proximal side is adapted to abut againstthe sub-annular surface of the native annulus. Preferably the externaldiameter of the mechanical stop 3 d ranges from 10 to 90 millimeters,preferably from 20 to 80 millimeters, more preferably from 30 to 70millimeters. According to one embodiment, the external diameter of themechanical stop 3 d is 20% larger than the diameter of the annulus ofthe native valve to be replaced.

If the extraventricular part 2 comprises only a single flange 6extending from the inner wall 5, after removing the ventricular part 3from the catheter 15, said ventricular part 3 expands and adopts a firstshape defining a mechanical stop. The outer wall 4 of the ventricularpart 3 indeed (i) protrudes with respect to the catheter 15 or to theextraventricular part 2 and (ii) presents proximally an angle rangingfrom 20° to 80° with respect to the longitudinal axis of the anchoringdevice 1. The external diameter of the mechanical stop is preferablyhigher than the internal diameter of the native heart valve, thus thesurgeon may abut the proximal part of the ventricular part 3 against thesub-annular surface of the heart valve annulus thereby obtaining amechanical feedback. Indeed the mechanical stop of the ventricular part3 defines an end-positon as the proximal side is adapted to abut againstthe sub-annular surface of the native annulus. Preferably the externaldiameter of the mechanical stop ranges from 10 to 90 millimeters,preferably from 20 to 80 millimeters, more preferably from 30 to 70millimeters. Moreover, in this embodiment, as the rim of the outer wall4 of the ventricular part 3 may displace longitudinally, when thesurgeon abuts the proximal part of the ventricular part 3 against thesub-annular surface of the annulus, the outer wall dampens the movementthereby obtaining a mechanical feedback.

Once the anchoring device 1 has been properly positioned (i.e. by properpositioning of the mechanical stop 3 d against the sub-annular surfaceof the heart valve), the surgeon may release, in a second step, theouter wall 4 of the extraventricular part 2, as illustrated in FIG. 3B.In an embodiment, as disclosed hereabove, the inner wall 5 of theextraventricular part 2 has a height higher than the height of the outerwall 4 of the extraventricular part 2. Said height difference allows asequential release—upon gradual retraction of the catheter sheath withregard to the anchoring device 1—of, first, the outer wall 4 of theextraventricular part 2 and, then, the inner wall 5 of theextraventricular part 2. In another embodiment, as disclosed hereabove,the inner wall 5 and the outer wall 4 of the extraventricular part 2have the same height. In said event the catheter 15 allows a sequentialrelease of, first, the outer wall 4 of the extraventricular part 2 and,then, the inner wall 5 of the extraventricular part 2 through any meansthat one with ordinary skill in the art would find suitable. In anotherembodiment, the outer wall 4 of the extraventricular part 2 has a heighthigher than the height of the inner wall 5 of the extraventricular part2.

At the stage shown in FIG. 3B, the surgeon may check the properanchoring and the error-free functioning of the anchoring device 1. Saidcheck may rely on the positioning and the validation provided by medicalimaging. At the stage shown in FIG. 3B, the native annulus is pinchedand pressed by the outer wall 4 of the anchoring device 1.

Once the surgeon has checked the proper sealing and the error-freefunctioning of the anchoring device 1, the surgeon may release, in athird step, the inner wall 5 of the extraventricular part 2, asillustrated in FIG. 3C.

After the release of the inner wall 5 of the extraventricular part 2,the surgeon may, if the anchoring device 1 comprises a prosthetic heartvalve 13 mounted on a prosthetic heart valve support 12, check for theproper functioning of said prosthetic heart valve 13. Once the surgeonhas checked the proper functioning of the prosthetic heart valve 13, hemay release from the catheter the tie 10 linking the anchoring device 1to the catheter 15.

According to an alternative embodiment, wherein the extraventricularpart 2 does not comprise an outer wall 4, once the surgeon has releasedthe ventricular part 3 and checked the proper sealing and the error-freefunctioning of the anchoring device 1, the surgeon may release theextraventricular part 2.

The anchoring device 1 of the present invention provides at a first stepof the deployment, after release of the ventricular part 3 out of acatheter 15, a mechanical stop 3 d which protrudes radially with respectto the catheter and presents an angle of about 90° with respect to thelongitudinal axis of the anchoring device. In the event of thedeployment inside a human body, said mechanical stop 3 d allows optimalpositioning of the device 1 with respect to the native heart valve. In asecond step, after release out of the catheter 15 of the outer wall 4 ofthe extraventricular part 2 said mechanical stop 3 d returns to itsoriginal shape. In the event of the deployment inside a human body, saidmechanical stop 3 d matches the shape of the heart wall and providesoptimal geometrical anchorage. In other words, in a first step theproximal part of the ventricular part 3 presents an angle of about 90°for preventing the crossing of the native heart valve and after releaseof the outer wall 4 of the extraventricular part 2, the proximal part ofthe ventricular part 3 presents an angle, with respect to thelongitudinal axis and in the direction of the ventricular part, rangingfrom 20° to 80°, preferably from 30° to 60°, more preferably from 40 to50° for matching with the distal part of the native heart valve. Thusthe anchoring device of the present invention provides, during a firststep of the implantation, a mechanical stop which, after a second stepdeforms for matching the heart walls. After the second step, the surgeonmay check proper positioning and sealing of the anchoring device andtake the decision of re-introducing the anchoring device 1 in thecatheter 15. In a third step, the surgeon may release the inner wall 5of the extraventricular part 2. After the third step the surgeon maycheck for the proper functioning of the prosthetic heart valve 13, ifapplicable; and then may release the tie 10 still connecting theanchoring device 1 and the catheter 15. In the second step, as depictedin FIG. 3B, the outer wall 4 adopts the expanded configuration with aV-shaped groove 8. After the surgeon positioned the anchoring device 1with the mechanical stop 3 d abutting against the sub-annular surface,the V-shape groove 8 enables self-positioning of the anchoring device 1by centering the anchoring device 1 with respect to the heart valveapparatus and especially with respect to the annulus. Indeed, due to theV-shaped groove 8, the anchoring device 1 is (i) positioned in the planeof the native annulus, (ii) centered in the plane of the native annulusand also maintained in said plane, thereby preventing migration. TheV-shaped groove 8 precisely maintains and contains the native annulusbetween the edges of the groove.

In an embodiment, the anchoring device 1 may be used for anchoring aprosthetic heart valve in a patient's heart by implementing thefollowing steps:

-   -   providing a catheter 15 comprising a crimped anchoring device 1,        wherein the ventricular part 3 is located distally and the        extraventricular part 2 is located proximally within said        catheter 15;    -   expanding the ventricular part 3 in the ventricle, so that the        ventricular part 3 provides a mechanical stop 3 d, which        prevents crossing the native heart valve;    -   positioning the anchoring device 1 in the patient's heart so        that the proximal part of the mechanical stop 3 d abuts over the        distal surface of the patient's native heart valve; and    -   expanding the extraventricular part 2 so that:    -   the extraventricular part 2 lies over a proximal surface of the        patient's native heart valve;    -   the mechanical stop 3 d deforms itself and fits with the distal        surface of the patient's native heart valve; and    -   the V-shaped groove 8 contains the native annulus and centers        the anchoring device 1 with respect to said annulus.

In an embodiment, the anchoring device 1 is expanded by self-expansionor by means of an expansion arrangement such as for example a balloon,as well known to those skilled in the art. However, when the anchoringdevice 1 comprises a prosthetic heart valve 13, the expansion isachieved only by self-expansion. In an embodiment, the anchoring device1 may be oversized with respect to the patient's anatomy in order toensure constant pressure and prevent slipping of the anchoring device 1by applying additional stresses to the surrounding tissues.

After full deployment of the anchoring device 1, geometrical anchorageis achieved. FIGS. 4A, 4B and 4C illustrate the geometrical anchorage ofthe anchoring device 1. The geometrical anchorage relies on a radialsealing (preventing paravalvular leakage) and on a longitudinalanchorage. As shown in FIGS. 4A, 4B and 4C, the anchoring device 1prevents slipping with respect to the heart wall due to longitudinalanchorage on each side of the annulus, especially due to the V-shapedgroove 8 and optionally the plurality of arms 16 and the grabbingmechanism.

In the event of mispositioning, prosthetic heart valve malfunction orparavalvular leak, the anchoring device 1 must be retrievable into thecatheter 15.

In an embodiment wherein the outer wall 4 has not been deployed (i.e.before the second step), the anchoring device 1 is be re-introduced inthe catheter 15 by traction of the device inside the catheter 15.

In an embodiment wherein the outer wall 4 has been deployed (i.e. afterthe second step) and wherein a tie 10 connects the catheter 15 to theouter wall 4 of the anchoring device 1, the anchoring device 1 may bere-introduced in the catheter 15 by traction on the tie 10. Saidtraction on the tie 10 affects the outer wall 4 of the extraventricularpart 2 of the anchoring device 1 from an expanded state to a collapsedor crimped state, enabling re-introduction of the whole device insidethe catheter 15.

In an embodiment, wherein the outer wall 4 has been deployed (i.e. afterthe second step) and wherein a tie 10 connects the catheter to the innerwall 5 of the anchoring device 1, re-introduction cannot be achieved asexplained hereabove and must be achieved by turning the outer wall 4inversely, as illustrated in FIG. 5.

In FIG. 5A, the inner wall 5 of the extraventricular part 2 is locatedinside the catheter 15. Said embodiment may be achieved either after thesecond step of the deployment or after the third step of the deploymentby traction on the tie 10 enabling (i) crimping of the inner wall 5 ofthe extraventricular part 2 of the anchoring device 1, and (ii) partialre-introduction of the inner wall 5 of the extraventricular part 2 ofthe anchoring device 1 in the catheter 15. By further traction on theproximal part of the anchoring device 1, the anchoring device 1 will besequentially re-introduced inside the catheter 15: first the whole innerwall 5 of the extraventricular part 2 (cf. FIG. 5B), then the inner wall5 of the ventricular part 3, the outer wall 4 of the ventricular part 3(cf. FIG. 5C) and finally the outer wall 4 of the extraventricular part2 (cf. FIG. 5D). During the retraction of the anchoring device 1 insidethe catheter 15, the outer wall 4 turns inversely (i.e. folded intoitself outwardly). In an embodiment, once the anchoring device 1 hasbeen re-introduced inside the catheter 15, the anchoring device 1 maynot be re-used.

The following description is related to the deployment of the anchoringdevice 1 out of a catheter 15, wherein the distal end of the catheter 15is located in an atrium or an artery before the beginning of thedeployment (cf. FIG. 9). The extraventricular part 2 is thus locateddistally and the ventricular part 3 is located proximally within thelumen of the catheter 15. Said deployment is illustrated in FIGS. 6A,6B, 6C and 6D.

Once the distal end of the catheter 15 has been inserted inside anatrium or an artery, the catheter 15 is sequentially retracted withrespect to the anchoring device 1. First the extraventricular part 2(i.e. the cylindrical portion 7, if applicable, and the extraventricularflange(s) 6) of the anchoring device 1 is fully released. In said firststep, the extraventricular flange 6 expands immediately and adopts afirst shape defining a mechanical stop 2 d, as shown in FIG. 6A. Saidextraventricular flange 6 indeed (i) protrudes with respect to thecatheter 15 or to the ventricular part 3 and (ii) presents proximally anangle of about 90° with respect to the longitudinal axis of theanchoring device 1. The external diameter of the mechanical stop ispreferably higher than the internal diameter of the native heart valve,thus the surgeon may abut the proximal part of the extraventricular part2 against the super-annular surface of the heart valve annulus therebyobtaining a mechanical feedback. Indeed the mechanical stop 2 d of theextraventricular part 2 defines an end-positon as the proximal side isadapted to abut against the super-annular surface of the native annulus.Preferably the external diameter of the mechanical stop 2 d ranges from10 to 90 millimeters, preferably from 20 to 85 millimeters, morepreferably from 30 to 70 millimeters.

Once the anchoring device 1 has been properly positioned (i.e. by properpositioning of the mechanical stop 2 d against the super-annular surfaceof the heart valve), the surgeon may release, in a second step, theouter wall 4 of the ventricular part 3, as illustrated in FIGS. 6B and6C. At the stage shown in FIG. 6C, the surgeon may check the error-freefunctioning of the anchoring device 1. Said check may rely on thepositioning and the validation provided by medical imaging. At the stageshown in FIG. 6C, the native annulus is pinched and pressed by theV-shaped groove 8 of the anchoring device 1.

Once the surgeon has checked the error-free functioning of the anchoringdevice 1, the surgeon may release, in a third step, the inner wall 5 ofthe ventricular part 3, as illustrated in FIG. 6D.

After the release of the inner wall 5 of the ventricular part 3, thesurgeon may, if the anchoring device 1 comprises a prosthetic heartvalve 13 mounted on a prosthetic heart valve support 12, check for theproper functioning of said prosthetic heart valve 13.

The anchoring device 1 of the present invention provides at a first stepof the implantation, after release of the extraventricular part 2, amechanical stop 2 d which protrudes radially with respect to thecatheter 15 and presents an angle of about 90° with respect to thelongitudinal axis of the anchoring device 1. In the event of thedeployment inside a human body, said mechanical stop 2 d allows optimalpositioning of the device 1 with respect to the native heart valve. In asecond step, after release of the outer wall 4 of the ventricular part 3said mechanical stop 2 d return to its original shape. In the event ofdeployment inside a human body, said mechanical stop 2 d matches theshape of the heart wall and provides optimal geometrical anchorage. Inother words, in a first step the proximal part of the extraventricularpart 2 presents an angle of about 90° for preventing the crossing of thenative heart valve and after release of the outer wall 4 of theventricular part 3, the proximal part of the extraventricular part 2presents an angle, with respect to the longitudinal axis and in thedirection of the ventricular part, ranging from 65° to 110°, preferablyfrom 75° to 100°, more preferably from 85° to 105° for matching with thedistal part of the native heart valve. Thus the anchoring device of thepresent invention provides, during a first step of the implantation, amechanical stop which, after a second step deforms for matching theheart walls. After the second step, the surgeon may check properpositioning and sealing of the anchoring device 1 and take the decisionof re-introducing the anchoring device 1 in the catheter 15. In a thirdstep, the surgeon may release the inner wall 5 of the ventricular part3. After the third step the surgeon may check for the proper functioningof the prosthetic heart valve 13, if applicable. In the second step, asdepicted in FIGS. 6C and 6D, the outer wall 4 adopts the expandedconfiguration with a V-shaped groove 8. After the surgeon positioned theanchoring device 1 with the mechanical stop 2 d abutting against thesuper-annular surface, the V-shape groove 8 enables self-positioning ofthe anchoring device 1 by centering the anchoring device 1 with respectto the heart valve apparatus and especially with respect to the annulus.Indeed, due to the V-shaped groove 8, the native annulus is centered inthe bottom of the groove, precisely maintaining and containing thenative annulus between the edges of the groove.

In an embodiment, the anchoring device 1 may be used for anchoring aprosthetic heart valve in a patient's heart by implementing thefollowing steps:

-   -   providing a catheter 15 comprising a crimped anchoring device,        wherein the extraventricular part 2 is located distally and the        ventricular part 3 is located proximally within said catheter        15;    -   expanding the extraventricular part 2 in an atrium or an artery,        so that the extraventricular part 2 provides a mechanical stop 2        d, which prevents crossing the native heart valve;    -   positioning the anchoring device in the patient's heart so that        the proximal part of the mechanical stop 2 d abuts over the        distal surface of the patient's native heart valve; and    -   expanding the ventricular part 3 so that:    -   the ventricular part 3 lies over a proximal surface of the        patient's native heart valve;    -   the mechanical stop 2 d deforms itself and fits with the distal        surface of the patient's native heart valve; and    -   the V-shaped groove 8 contains the native annulus and centers        the anchoring device 1 with respect to said annulus.

In an embodiment, the anchoring device 1 is expanded by self-expansionor by means of an expansion arrangement such as for example a balloon,as well known to those skilled in the art. In an embodiment, theanchoring device 1 may be oversized with respect to the patient'sanatomy in order to ensure constant pressure and prevent slipping of theanchoring device 1 by applying additional stresses to the surroundingtissues. After full deployment of the anchoring device 1, geometricalanchorage is achieved as explained hereabove and as illustrated in FIGS.4A, 4B and 4C.

In the event of mispositioning, prosthetic heart valve malfunction orparavalvular leak, the anchoring device 1 must be retractable into thecatheter 15. Said re-introduction is achievable until the stepillustrated in FIG. 6B, i.e. before the full deployment of the outerwall 4 of the ventricular part 3. In an embodiment wherein the outerwall 4 of the ventricular part 3 has not been fully deployed, theanchoring device 1 may be re-introduced in the catheter 15 by tractionof the anchoring device 1 inside the catheter 15.

The present invention also relates to an anchoring system designed forimplantation of a prosthetic heart valve in a mammalian heart.

In an embodiment, the anchoring system 11 comprises an anchoring device1, a prosthetic heart valve support 12 and a prosthetic heart valve 13mounted in the prosthetic heart valve support 12, preferably aprosthetic heart valve 13. In an alternative embodiment, the prostheticheart valve is directly mounted in the anchoring device and theanchoring system does not comprise a prosthetic heart valve support.

In an embodiment, the prosthetic heart valve support 12 is designed forsupporting the prosthetic heart valve 13. In an embodiment, theprosthetic heart valve support 12 has a circular cross-section with adiameter higher or equal to D4. In another embodiment, the prostheticheart valve support 12 has a D-shape cross-section. In an embodiment,the prosthetic heart valve support 12 has a constant cross-section alongits length. In another embodiment, the cross-section of the prostheticheart valve support 12 differs along its length. In an embodiment, thelength of the prosthetic heart valve support 12 ranges from 5 to 50millimeters, preferably from 10 to 40 millimeters, more preferably from15 to 35 millimeters. In an embodiment, the length of the prostheticheart valve support 12 is equal or higher than the length of theprosthetic heart valve 13 intended to be inserted inside the prostheticheart valve support 12. In an embodiment, the length of the prostheticheart valve support 12 is lower, equal or larger than the height 113 ofthe ventricular part 3. In an embodiment, the prosthetic heart valvesupport 12 is adapted for minimizing turbulence in the blood flow.

In an embodiment, the prosthetic heart valve support 12 is made as aseparate part with respect to the anchoring device 1. In anotherembodiment, the prosthetic heart valve support 12 is made in a singlepiece with the anchoring device 1 (i.e. with the inner wall 5 of theventricular part 3). In another embodiment, the prosthetic heart valve13 is directly attached to the anchoring device 1 without any prostheticheart valve support 12. In a preferred embodiment, the prosthetic heartvalve 13 is not mounted directly inside the inner wall 5. In anembodiment, the prosthetic heart valve support 12 is located inside theinner wall 5 of the ventricular part 3. In an embodiment, the prostheticheart valve support 12 is solidarily attached to the anchoring device 1.In an embodiment, the prosthetic heart valve support 12 is solidarilyattached to the inner wall 5 of the ventricular part 3. In anembodiment, the prosthetic heart valve support 12 is attached to theanchoring device 1 by any means that one of ordinary skill in the artwould find suitable, such as for example suture, bonding, welding ormesh interlacing. In an embodiment, the prosthetic heart valve support12 is linked to the to the inner wall 5 of the ventricular part 3 by anymeans that one of ordinary skill in the art would find suitable, such asfor example suture, bonding, welding or mesh interlacing.

In an embodiment, the prosthetic heart valve support 12 is made of amesh for ensuring attachment with the prosthetic heart valve 13. In anembodiment, said mesh is a flexible, compressible and expansible mesh.In an embodiment, the mesh of the prosthetic heart valve support 12 is abraided mesh or a continuous mesh obtained, for example, by lasercutting. In an embodiment, the mesh size is adapted for matching withthe rim of the leaflets of the prosthetic heart valve 13. In anembodiment, the prosthetic heart valve 13 is attached to the prostheticheart valve support 12 by any means that one of ordinary skill wouldfind suitable, such as for example suture. In an embodiment, theprosthetic heart valve 13 is centered in the prosthetic heart valvesupport 12. In an embodiment, the prosthetic heart valve 13 ispositioned completely inside the prosthetic heart valve support 12.

In an embodiment, the prosthetic heart valve support 12 is made from anymaterial from any material that one skilled in the art would findsuitable, such as any biocompatible material. In an embodiment, theprosthetic heart valve support 12 is made from any biocompatible alloythat one skilled in the art would find suitable such as for example acobalt alloy, preferably a cobalt-chromium alloy; steel, preferablystainless steel; or a biocompatible shape memory alloy. In anembodiment, the prosthetic heart valve support 12 is made from a shapememory alloy, preferably Nitinol, allowing faster and easier deploymentand return to its original expanded shape. In an embodiment, thetransformation temperature of the shape memory alloy, preferablyNitinol, ranges from 0° C. to 50° C. In an embodiment, thetransformation temperature of the shape memory alloy is about 37° C. Inanother embodiment, the transformation temperature of the shape memoryalloy, preferably Nitinol, ranges from 0° C. to 20° C. in order to allowphase transformation immediately from the releasing of the prostheticheart valve support 12.

In an embodiment, a cover 14 covers the prosthetic heart valve support12 in order to prevent leaks between the prosthetic heart valve support12 and the inner wall 5 of the anchoring device 1. In an embodiment,contacting the cover 14 of the prosthetic heart valve support 12 withthe cover 9 of the anchoring device 1 prevents paravalvular orparaprosthetic leaks. In an embodiment, a cover 14 internally orexternally covers the prosthetic heart valve support 12. In anembodiment, said cover 14 partially or totally covers the prostheticheart valve support 12. In an embodiment, the cover 14 internally coversthe prosthetic heart valve support 12 from 1 to 15 millimeters,preferably from 2 to 10 millimeters, below the distal end of theprosthetic heart valve 14. In an embodiment, the cover 14 internallycovers the prosthetic heart valve support 12 from 1 to 15 millimeters,preferably from 2 to 10 millimeters, above the proximal end of theprosthetic heart valve 14. In an embodiment, the cover 14 comprises twocovers internally covering the prosthetic heart valve support 12 from 1to 15 millimeters, preferably from 2 to 10 millimeters, on each side ofthe prosthetic heart valve 13.

FIG. 7A illustrates a cross-sectional view of the anchoring system 11comprising the anchoring device 1, the prosthetic heart valve support 12and the prosthetic heart valve 13. As shown, the prosthetic heart valvesupport 12 may extend beyond the anchoring device 1.

FIG. 7B illustrates a top perspective view of the anchoring system 11.As shown, the anchoring system 11 comprises two covers (9 and 14), aprosthetic heart valve support 12 and a prosthetic heart valve 13. Asshown, the prosthetic heart valve support 12 may extend beyond theextraventricular flanges 6 of the anchoring device 1 and the cover 14may covers the prosthetic heart valve support 12 above the prostheticheart valve 13.

FIG. 7C illustrates a bottom perspective view of the anchoring system11. As shown, the anchoring system 11 comprises the anchoring device 1,a prosthetic heart valve support 12, a prosthetic heart valve 13 and acover 14. As shown, the prosthetic heart valve support 12 may extendbeyond the anchoring device 1 and the cover 14 may covers the prostheticheart valve support 12 below the prosthetic heart valve 13.

In an embodiment, the cover of the prosthetic heart valve support 12 orthe cover of the anchoring device 9 are preferably a film or a fabric,preferably a biocompatible and nonthrombogenic film or fabric. In anembodiment, the cover of the prosthetic heart valve support 12 or thecover of the anchoring device 9 may be any biological (such as animaltissue) or synthetic material that one skilled in the art would findsuitable. In an embodiment, the cover of the prosthetic heart valvesupport 12 or the cover of the anchoring device 9 are made fromsilicone, polytetrafluoroethylene, polyurethane, polyamide, polyester ormixture thereof. In an embodiment, the cover of the prosthetic heartvalve support 12 or the cover of the anchoring device 9 may presentnatural resorption in the human body thus allowing anchorage by humancells after implantation. In an embodiment, the cover of the prostheticheart valve support 12 or the cover of the anchoring device 9 aredesigned so that to allow optimal crimping and release of the anchoringdevice 1. In one embodiment, the cover of the prosthetic heart valvesupport 12 and the cover of the anchoring device 9 are made from thesame or different materials.

In an embodiment, the prosthetic heart valve support 12 presents highstiffness. In an embodiment, the stiffness of the prosthetic heart valvesupport 12 is higher than the stiffness of the anchoring device 1. In anembodiment, the outer wall 4 has a lower stiffness than the inner wall 5linked to the prosthetic heart valve support 12. Optimal functioning(i.e. proper opening and closing of the leaflets over years) of theprosthetic heart valve 13 requires a substantially symmetric andcylindrical support around the prosthetic heart valve 13. Thus theprosthetic heart valve support 12 is designed so that thecross-sectional shape remains stable during each cardiac cycle. In anembodiment, the outer wall 4 is mechanically isolated from theprosthetic heart valve support 12 such that the cross-sectional shape ofthe prosthetic heart valve support 12 remains stable and the prostheticheart valve 13 remains competent when the anchoring device 1 is deformedin a non-circular shape in use, after implantation. The anchoring device1 and the anchoring system 11 effectively absorb the distorting forcesapplied by the patient's anatomy. The anchoring system 11 has thestructural strength integrity necessary to withstand the dynamicconditions ofthe heart over time, thus permanently anchoring areplacement heart valve and making it possible for the patient to resumesubstantially normal life.

In an embodiment, the anchoring system 11 and device 1 enable apercutaneous approach using a catheter 15 delivered through a vein or anartery into the heart or through the apex of the heart. Additionally,the embodiments of the system 11 and device 1 as described herein can becombined with many known surgeries and procedures. In an embodiment, theanchoring system 11 of the present invention is to be used for patientssuffering from tricuspid insufficiency, mitral insufficiency, aorticvalve insufficiency, pulmonary valve insufficiency, tricuspid stenosis,mitral stenosis, aortic valve stenosis or pulmonary valve stenosis.

The release and/or re-introduction of the anchoring device 1 out ofand/or in the catheter 15 as disclosed in the detailed descriptionhereabove is similar to the release and/or re-introduction of theanchoring system 11 comprising the anchoring device 1, the prostheticheart valve support 12 and the prosthetic heart valve 13, as a personskilled in the art can easily understand. In an embodiment, thedeployment or release of the anchoring device 1 is concomitant with thedeployment or release of the prosthetic heart valve 13.

According to one embodiment, as depicted in FIG. 13, the anchoringsystem 11 further comprises a plurality of arms 16 for securing thesystem with respect to the native heart valve. The plurality of arms 16extends outwardly from the prosthetic heart valve support 12. Accordingto one embodiment, the plurality of arms extends outwardly from theventricular end of the prosthetic heart valve support 12 in thedirection of the extraventricular part 2. Said plurality of arms 16 areconfigured to be size and shape for providing a positioning andanchoring function when the anchoring system 11 is deployed at thenative heart valve location.

In one embodiment, the plurality of arms 16 has a length sufficient toextend completely into engagement with the annulus tissue behind theleaflets. In another embodiment, the plurality of arms has a shorterlength for remaining on the inner sides of the leaflets. According toone embodiment, the plurality of arms 16 comprises arms with differentlength and modes of engagement with the leaflets or other native tissue.

The plurality of arms 16 may alternatively be configured to engage orcouple to the chordae, papillary muscles or ventricular walls to enhanceanchoring. In one embodiment, each arms of the plurality of arms 16 haveindependent lengths. In one embodiment, the native leaflets are pinchedor sandwiched between the plurality of arms 16 and the outer wall 4.

According to one embodiment, the plurality of arms 16 is formedintegrally with the prosthetic heart valve support 12. According toanother embodiment, the plurality of arms 16 is separate component thatare attached to the prosthetic heart valve support 12. According to oneembodiment, the plurality of arms 16 is made from the same material thanthe prosthetic heart valve support 12 of the anchoring system 11.

The present invention also relates to a kit for performing heart valvereplacement comprising an anchoring device 1, a prosthetic heart valvesupport 12, a prosthetic heart valve 13 connected to said prostheticheart valve support 12, and optionally a catheter 15.

What is claimed is:
 1. A method of treating heart valve disease comprising: providing an anchoring system for positioning a prosthetic heart valve inside a heart, the system comprising an expandable anchoring device, a prosthetic heart valve support, and a prosthetic heart valve mounted in the prosthetic heart valve support, wherein the anchoring device comprises a groove for accommodating the native valve; positioning the system such that the groove resides between the ventricle and the atrium or artery.
 2. The method of claim 1, wherein the groove is between a ventricular part and an extraventricular part of the anchoring device.
 3. The method of claim 1, wherein contact between a bottom of the groove and an annulus is avoided.
 4. The method of claim 1, wherein the groove allows the anchoring device to be self-positioning.
 5. The method of claim 1, wherein the prosthetic heart valve is a tricuspid heart valve.
 6. The method of claim 1, wherein the method includes a step of anchoring the anchoring system to the native heart tissue.
 7. The method of claim 1, wherein the groove is a V-shaped groove.
 8. The method of claim 1, wherein the groove has a depth of 5 to 15 mm.
 9. The method of claim 1, wherein the groove is defined by two inclined walls.
 10. The method of claim 1, wherein the anchoring device is configured to pinch sub- and supra-annular surfaces of an annulus without applying radial force on the annulus.
 11. The method of claim 1, wherein the anchoring device is compressible and the method includes crimping the anchoring device into a radially collapsed configuration.
 12. The method of claim 11, wherein the method includes introducing the crimped anchoring device into a lumen of a catheter.
 13. The method of claim 12, wherein the method includes delivering the crimped anchoring device in the radially collapsed configuration with the catheter.
 14. The method of claim 13, wherein the method includes deploying the anchoring device from the catheter.
 15. The method of claim 14, wherein the deploying includes radially expanding the crimped anchoring device.
 16. The method of claim 15, wherein the anchoring device is folded into itself before or after the step of delivering the anchoring device.
 17. The method of claim 15, wherein the anchoring device comprises, before use, an outer wall and an inner wall connected at a folded end.
 18. The method of claim 15, wherein the method includes advancing a distal end of the catheter until the distal end crosses a targeted native heart valve.
 19. The method of claim 18, wherein the method includes one or any combination of: i) after the distal end of the catheter has been inserted inside the ventricle, sequentially retracting the catheter with respect to the anchoring device; ii) releasing the ventricular part of the anchoring device; iii) expanding the ventricular part to adopt a first shape defining a mechanical stop, wherein an outer wall of the ventricular part protrudes with respect to the catheter or to the extraventricular part, and the outer wall of the ventricular part presents proximally an angle of about 90° with respect to a longitudinal axis of the anchoring device; iv) abutting a proximal part of the ventricular part against a sub-annular surface of a native annulus; v) releasing an outer wall of the extraventricular part; or vi) releasing an inner wall of the extraventricular part.
 20. The method of claim 19, wherein the method includes releasing the ventricular part, releasing the outer wall of the extraventricular part, and releasing the inner wall of the extraventricular part as three separate sequential steps. 